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Is The MDI FDA approved?
Contrary to common beliefs, the FDA doesn't "approve"
any medical or dental device. Prior to his preliminary
discussions with Dr. Bulard, Dr. Sendax had submitted
a formal application to the FDA Washington, D.C. seeking
permission to market the mini dental implant devices
to the general public. After providing satisfactory
technical & clinical evidence to that agency that
the product was safe for public use & in fact had
beneficial attributes, the FDA granted its formal consent
to market the MDI device not only as a transitional
or temporary dental product, but significantly, as an
on-going item. No competitor dental product can make
this claim.
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When
can they be used?
When critically needed for support purposes,
and where solid bony adaptation (integration) has clearly
occurred, mini implants can function as long-term supporting
structures rather than as short-term or medium term
devices. In fact, some have been successfully
functioning in patients’ jaws for several decades.
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What's the primary &
most effective use for them?
The most effective use of this unique dental product
is stabilization of a mandibular denture. There
are approximately 50,000 people in the United States
who are “edentulous” (literally meaning lacking teeth)
who struggle daily with prosthetic devices. A majority
suffers a great deal of discomfort as a result of loose
or ill-fitting dentures. Also, many denture wearers
simply withdraw from any type of social engagement as
a result of being compelled to wear them. Moreover,
it’s not uncommon for family members to complain about
denture prosthesis. Successful placement of the MDI
addresses and solves all of these social and practical
problems.
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How specifically can mini
dental implants help denture wearers?
The standard insertion protocol for mini dental implants calls for four of them to be gently screwed into the
front of a patient’s lower jaw, or mandible. This
is a relatively painless procedure that can be performed
by a general dentist, requiring only a mild anesthesia. The
mini implants, which are approximately the size of wooden
toothpicks, are placed about four millimeters apart
in the patient’s mandible. The patient’s denture
is then carefully adjusted by the dentist to allow it
to snap onto the four mini implants. The result ? A
tight fitting, completely reliable system that allows
a patient to speak and eat with confidence. All performed
in about an hour’s time. Because of the unique,
minimally invasive procedure, the minute size of the
implants, and the characteristic placement area, the
typical MDI patient can enjoy a light meal within an
hours time from having the mini implants placed.
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I'm somewhat aware of the
tremendous forces the human jaw endures during normal
chewing of food. How can these tiny implants withstands
that?
It’s true that what the dental profession calls occlusal
forces create dynamic pressures on the human jaw.
Our jaws are marvelously designed to adequately withstand
those forces. It’s also true that mankind has
been struggling for centuries to come up with some type
of metal or metallic element that can efficiently withstand
those forces. Most have been outright failures.
However, approximately twenty-five years ago some doctors
around the world began experimenting with titanium as
a potential dental medium. Titanium is an extremely
strong metal used in the construction of aircraft and
aircraft engines. The metal, in its commercial
form, is incredibly strong and durable. The Sendax MDI
takes that metallurgical concept to the next level by
adapting an industry approved mixture of commercially
pure titanium, a small percentage of aluminum, and a
tiny sample of vanadium, likewise a malleable metallic
element. The result is the strongest metal on
earth, now commonly referred to as titanium alloy. In
fact, extensive tests conducted several years ago by
the University of Alabama-Birmingham School of Orthopedics
revealed that the particular titanium alloy implants
used in the IMTEC Sendax MDI’s are 64% stronger than
ones constructed of commercially pure titanium. The
bottom line of this discussion area is simple: if a
denture patient has sufficient bone mass to create a
rock hard placement of the tiny implant, which an experienced
dentist can usually determine by an initial examination,
the mini dental implants will generally withstand normal
occlusal forces just like natural teeth. Fractures
are extremely rare, but as the case with a person’s
normal teeth, can certainly occur.
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You've told us about the
diameter of the implants. How long are they?
IMTEC Corporation manufactures and sells the implants in four lengths, 10, 13, 15 & 18 mm’s. One
trained in dental science will recognize instantly that
these lengths approximately anticipate the type of depths
that are needed in a wide variety of prospective MDI
patients. The company also manufactures what it
calls the MDI MAX that’s sold in 10, 13 & 15mm’s. The
use of the MAX is explained in the next question.
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I've been told by my dentist
that my jaw bone is not "dense". Is this a
problem with the MDI? Will a dentist be able to get
a rock-solid resistance state in such a situation?
After utilizing the standard MDI’s in his practice,
steps have been taken to expand IMTEC Corporation’s
original production offering to provide an MDI MAX implant.
Equipped with the same dimensions as the standard ones,
the MAX has a different thread design that enables the implant to bite into softer bone and hold. It’s
ideal for a patient whose bone density is lacking.
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What about failures?
It must be recognized that all implant systems as well
as natural teeth are subject to potential failure due
to natural causes, including osteoporosis, poor oral
hygiene, wear and tear attrition, poor health, heavy,
stressful biting habits, and lack of follow-up dental maintenance care. Mini implants similarly do not
carry any actual or implied guarantee as to longevity.
However, the loss of a mini implant is a far less critical
event to the patient since it may be replaced at relatively
minimal cost compared to conventional implants, and
with minimal associated bone or gum deterioration.
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How are mini implants different?
As a revolutionary departure from routine implant methods,
mini implants are so narrow they are typically inserted
directly through the overlying gum tissue and into the
bone underneath. Consequently the need to surgically
cut and “flap” open the gum tissue, routinely required
for standard implant systems, is avoided in most MDI
applications. As a result, post-insertion irritation
and soreness is significantly reduced. While all
dental implants require care during insertion to avoid
encroaching on vulnerable nerve, sinus or bony structures,
the ultra small width of the mini implants offers a
much more comfortable margin of safety.
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What type surgery is involved?
A single, minimally invasive surgery is needed for insertion
of the MDI mini implants. They are then put into immediate
biting or “loading” function thanks to their “self-tapping”
design, thereby anchoring a fixed bridge system. As
a result, it is often possible to provide the complete
mini implant service in a single office visit. Mini
dental implants clearly represent an enormous breakthrough
for the dental implant specialty as the most patient-friendly,
cost-effective, proven implant system available today.
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What's a typical daily routine
one might expect once the MDI's have been placed?
As with all dental applications, there’s a short adjustment
period during which time the MDI patient becomes comfortable
placing and removing the denture. Typically, this
involves removal of the lower denture in the morning,
brushing the gums and implant area with an ACCESS curved
bristle toothbrush, rinsing the mouth, rinsing the denture
itself, then replacing it. The result is a normal
days activity for the patient, including eating, talking,
taking a nap, etc. Then, in the evening, the denture
is usually removed again, the ACCESS brush is used,
and the mouth thoroughly rinsed. The MDI patient
then opts to sleep with, or without his or her denture. The
result is a fully functioning dental appliance that
works, is socially acceptable, has a comfortable fit,
etc.
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How can I find out more about
the IMTEC Sendax MDI?
If your computer is connected to the Internet, log onto
IMTEC’s website, www.imtec.com, and click on the Sendax
MDI portion. You’ll get a lot of information there.
For dentists in your locale who are placing the MDI,
click on Doctor Locator. Remember, this wonderful
procedure is relatively new, and dentists and oral surgeons
who have learned the system and have bad experience
in placing it, are likewise growing in number.
More are being added to the company’s website each business
day, however. While you’re at IMTEC’s site, check
out the ACCESS curved bristle toothbrush that is specially
designed to complement the MDI’s in so far as oral hygiene
is concerned. It’s a perfect brush for implant patients.
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I've been heard that standard
dental implants are somewhat expensive. What about these?
It goes without saying that dentists set their own fees
based on a wide variety of factors. As you would
expect, fees vary around the country and from doctor
to doctor. The best way to address this issue is
to engage your dentist of choice in a frank discussion
about what to expect insofar as fees are concerned. In
considering the costs of an MDI placement, bear in mind
the costs of dentures and the costs of required periodic
adjustments that can be expensive. Plus, by choosing
the MDI, you’ve chosen an enhanced way of life free
of a lot of the discomforts and heartaches of a loose
or ill-fitting denture. That’s worth a lot.
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